Medicine

Sanofi And Regeneron To Increase Praluent Accessibility For High-Risk Patients

Sanofi And Regeneron To Increase Praluent Accessibility For High-Risk Patients

The new price will be in alignment with a value assessment for this population from the Institute for Clinical and Economic Review (ICER).

A newer cholesterol drug, used with older statin medicines, modestly lowered heart risks and deaths in a big study of heart attack survivors that might persuade insurers to cover the pricey treatment more often.

Long-awaited data from the 18,924 patient ODYSSEY OUTCOMES trial, announced at the American College of Cardiology's annual conference in Orlando, showed the study met its primary outcome. Praluent was also associated with a lower risk of death overall, known as "all-cause mortality", and there were also numerically fewer coronary heart disease (CHD) deaths.

After almost three years, 9.5 percent of those on Praluent and 11.1 percent of those on dummy medicine had suffered a heart attack, stroke, heart-related death or serious chest pain; 3.5 percent on Praluent and 4.1 percent on dummy medicine died.

Praluent significantly reduced risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome event such as a heart attack.

In a post-hoc analysis of this group, Praluent was associated with a lower risk of death from any cause by 29%.

Regeneron and Sanofi said on Saturday they would lower the net price of Praluent if onerous barriers to its access are removed for the highest-risk patients.

"Not all patients with heart disease are the same". "Because the treatment effect was so much more marked in the patients with the highest LDL cholesterol, we believe that these patients are the optimal candidates for therapy". The drugs have been sold since 2015 but cost more than $14,000 a year, and insurers have balked at paying without proof that they reduce health problems, not just the cholesterol number.




ICER's latest analysis sets a value-based price range of $4,500-8,000 per year, net of rebates and discounts, for this group, and the companies have said they will offer discounts of up to 69% to health insurers that reduce prescribing obstacles and will be meeting with United States health plans to discuss pricing adjustments. He says Amgen (AMGN -0.9%) would have to cut the price on Repatha (evolocumab) even more to grab market share.

"It may take years and years to really reap all the benefits that one can achieve", study co-chairman Dr. Gregory Schwartz said.

Sanofi also seems to have won over the doctors attending the conference, which will help it in the coming months as the battle with Amgen begins in earnest.

There were no new safety signals in the trial, with injection site reactions experienced more commonly in the Praluent group compared to patients on maximally-tolerated statins alone.

All patients randomly received Praluent or a placebo and were treated for an average (median) of 2.8 years, with some patients being treated for up to five years.

With an LDL target range of 25-50, rather than taking it as low as possible, three-quarters of patients ended up on a lower dose of Praluent and some were taken off the drug if their LDL remained at 15 or lower. They had LDL cholesterol at 70 mg/dL or above and non-HDL cholesterol 100 mg/dL or above. Management sees population of 300K - 400K high-risk patients in USA, only 38K being treated at present.

Data showed 730 patients stopped receiving Praluent while on the 75mg dose after experiencing two consecutive LDL-C measurements below 15 mg/dL while on the 75 mg dose.